Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation

Lung Diseases Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02611297
• Other study ID #: IIBSP-CRI-2013-142
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2015
• Last updated: November 19, 2015
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Virginia Pajares, MD, PhD
• Phone: +34935565972
• Email: vpajares[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• =18 years old

• Patients with mechanical ventilation.

• Patients with diffuse lung disease of unknown etiology.

• Need for confirming/excluding a diagnosis, with therapeutical and prognosis implications.

• Inform consent signed by family.

Exclusion Criteria:

• Use of anticoagulant therapy or presence of a coagulation disorder (abnormal platelets counts, international normalized ratio > 1.5).

• Comorbidities that could increase the risk of the TBLB.

• Bullous emphysema.

• Hemoptysis, pneumothorax.

• Severe respiratory insufficiency requiring PEEP >12 cm H2O

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Interstitial Disease
• Lung Diseases

Intervention

Procedure:
• Cryoprobe

Locations

Country	Name	City	State
Spain	Germans Tries i Pujol Hospital	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Germans Trias i Pujol Hospital, Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe		27 months	Yes
Secondary	Diagnostic yield of transbronchial lung biopsy (TBLB) obtained by cryoprobes		27 months	Yes